Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology (OSTEOPATHIE)

Léon Bérard Center

Status: Terminated

Conditions: Breast Cancer

Treatments: Other: Conventional analgesic treatments; Other: OSTEOPATHY + conventional analgesic treatments

Study type: Interventional

Funder types: Other

Identifiers

NCT01403168

OSTEOPATHIE

Details and patient eligibility

About

This is an open, prospective, controlled, randomized, comparative study with 2 arms.

The purpose of the study is to assess the efficacy of osteopathy after breast surgery.

80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.

Enrollment: 28 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• woman >= 18 years
• pain (median VAS >=3 on the week prior to inclusion)
• mastectomy or tumorectomy with axillary dissection <= 12 months
• PS <=2
• able to write, understand and read French
• signed informed consent

Exclusion criteria

• no pain
• immediate breast reconstruction
• history of cognitive or psychiatric troubles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups, including a placebo group

osteopathy + conventional analgesic treatments

Experimental group

Treatment:

Other: OSTEOPATHY + conventional analgesic treatments

conventional analgesic treatments

Placebo Comparator group

Treatment:

Other: Conventional analgesic treatments